Catalog Number CS-25802-E |
Device Problem
Insufficient Information (3190)
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Patient Problems
Anaphylactic Shock (1703); Low Blood Pressure/ Hypotension (1914); Tachycardia (2095)
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Event Date 11/25/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).
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Event Description
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The customer reports: the cvc was inserted during surgery on 25 nov.After the cvc placement, the patient's hr 130 bpm, bp 46/26 mmhg, etco2 15mmhg, airway pr.33 mmhg.Breathing sound clear.Patient was given levophed 20+20 mcg but not effective.R/o coating allergic reaction.Therefore, patient was given 0.4 mg epinephrine (total given 2mg), and hydrocortisone 100 mg.The arrow cvc was removed and a non-coating cvc was inserted.
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Manufacturer Narrative
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(b)(4).Additional information received from the customer indicates the condition of the patient was "fine".It was also reported that "the intervention was successful" and "the physician kept the wire to perform insertion with non-coating cvc".
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Event Description
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The customer reports: the cvc was inserted during surgery on 25 nov.After the cvc placement, the patient's hr 130 bpm, bp 46/26 mmhg, etco2 15mmhg, airway pr.33 mmhg.Breathing sound clear.Patient was given levophed 20+20 mcg but not effective.R/o coating allergic reaction.Therefore, patient was given 0.4 mg epinephrine (total given 2mg), and hydrocortisone 100 mg.The arrow cvc was removed and a non-coating cvc was inserted.
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Manufacturer Narrative
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Qn#(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.
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Event Description
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The customer reports: the cvc was inserted during surgery on 25 nov.After the cvc placement, the patient's hr 130 bpm, bp 46/26 mmhg, etco2 15mmhg, airway pr.33 mmhg.Breathing sound clear.Patient was given levophed 20+20 mcg but not effective.R/o coating allergic reaction.Therefore, patient was given 0.4 mg epinephrine (total given 2mg), and hydrocortisone 100 mg.The arrow cvc was removed and a non-coating cvc was inserted.
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Search Alerts/Recalls
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